Preparatory Aid to Improve Decision Making About Cancer Clinical Trials (PRE-ACT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 583
- 试验地点
- 4
- 主要终点
- Improvement in preparation for consideration of clinical trials
研究概览
简要总结
RATIONALE: Providing information that is tailored to answer patients' questions about clinical trials may help patients with cancer decide to enroll in a clinical trial. It is not known whether providing personalized information is more effective than basic information in helping patients make decisions about clinical trials.
PURPOSE: This randomized phase III trial is studying personalized information to see how well it works compared with basic information in helping patients make decisions about participating in a clinical trial.
详细描述
OBJECTIVES:
Primary
- To improve preparation for consideration of clinical trials by providing tailored information to address barriers related to knowledge, goals and values, and beliefs and expectancies before their physician visit in patients with advanced metastatic or early stage cancer.
Secondary
- To develop and pilot test a tailored interactive preparatory aid (PRE-ACT) to promote informed cancer treatment decision making by addressing barriers to considering clinical trials as a treatment option.
- To evaluate the efficacy of PRE-ACT in improving preparation for considering participation in clinical trials by conducting a randomized clinical trial to compare PRE-ACT vs generic clinical trial information with text (control condition).
- To investigate relevant background and psychosocial variables that are associated with preparedness, barriers, and treatment outcomes.
- To investigate the impact of PRE-ACT on patient decisional conflict, satisfaction with information received, satisfaction with discussion about clinical trials with the physician, satisfaction with the treatment decision, clinical trials discussion, clinical trials participation, and quality of informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of 1 of the following:
- •Advanced (metastatic) disease
- •Early stage (i.e., appropriate for adjuvant therapy) disease
- •Scheduled for first outpatient consultation with a medical oncologist at the Clinical Centers
- •PATIENT CHARACTERISTICS:
- •Able to read and verbally communicate in English
- •Patients who choose to complete the intervention at home rather than at the Clinical Center before their visit must have high-speed (i.e., DSL or cable) Internet access
- •PRIOR CONCURRENT THERAPY:
- •Not specified
排除标准
- 未提供
研究组 & 干预措施
Arm I (PRE-ACT)
Patients receive tailored feedback and video content to address clinical trial barriers following baseline assessment.
干预措施: educational intervention (Other)
Arm II (control)
Patients receive generic clinical trials educational feedback taken from NCI publications following baseline assessment.
干预措施: educational intervention (Other)
结局指标
主要结局
Improvement in preparation for consideration of clinical trials
时间窗: after pts.complete all survey measures
次要结局
- Development and pilot testing of a tailored interactive preparatory aid (PRE-ACT)(after pts.complete all survey measures)
- Efficacy of PRE-ACT(after pts.complete all survey measures)
- Comparison of PRE-ACT and genomic clinical trial information with text(after pts.complete all survey measures)
- Relevant background and psychosocial variables that are associated with preparedness, barriers, and treatment outcomes(after pts.complete all survey measures)
- Impact of PRE-ACT on patient(after pts.complete all survey measures)